List of Drug Master Files (DMF) for 19819 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Question

Looking for Drug Master Files (DMF) for 19819 of Farmhispania Sa

score 20 · Accepted Answer

Farmhispania Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.

One of their notable products is ROCURONIUM BROMIDE USP, with a corresponding US DMF Number 19819.

Remarkably, this DMF maintains an Active status since its submission on September 15, 2006, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 14, 2018, and payment made on July 27, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

List of Drug Master Files (DMF) for 19819 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Looking for Drug Master Files (DMF) for 19819 of Farmhispania Sa